Rheumatoid Arthritis
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, \[NCT01317797\]) to correlate genetic markers with clinical outcomes.
Detailed description
Participants who received treatment with namilumab in the previous study M1-1188-002-EM (PRIORA \[NCT01317797\]) will have two whole blood samples (3 mL each) collected to correlate genetic markers with namilumab treatment responses as determined in the previous study. The study will enroll approximately 14 participants who received namilumab in the previous study. • No intervention is administered in this study. This trial will be conducted in Bulgaria, Spain and The Netherlands. The overall time to participate in this study is 1 day.
Interventions
OTHERNo Intervention
No study drug will be administered in this study.
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. The participant (or, when applicable, the participant's legally acceptable representative) voluntarily signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion criteria
1. Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo controlled, randomized, dose-escalating study). 2. Participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point 3. Participants who were excluded from post-hoc analysis due to protocol violations during the previous PRIORA study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Cluster | Baseline | Clusters are described by an ellipse whose major and minor axes are the standard deviations in the x and y directions of the component points, which are rotated so that their covariance is equal to zero. The clusters were based upon the algorithms in which each data-point is assigned to one of four clusters: 1, 2, 3, or 4, representing no-target (negative controls \[NTCs\]), homozygotes one (XX), homozygotes two (YY), and heterozygotes (XY), respectively. Based on the calculated genetic composite scores from 8-single-nucleotide polymorphism (SNP)-based algorithm, participants were segregated into clusters. |
Participant flow
Recruitment details
Participants took part in the study at 5 investigative sites in The Netherlands, Bulgaria, and Spain from 19 November 2015 to 05 April 2016.
Pre-assignment details
Participants with a historical diagnosis of mild or moderate rheumatoid arthritis who received namilumab (MT203) in the study M1-1188-002-EM (NCT01317797) were enrolled in this study to obtain and analyze a blood deoxyribonucleic acid (DNA) sample.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized Adults (18-64 years) | 5 participants |
| Age, Customized Adults (65-84 years) | 3 participants |
| Race/Ethnicity, Customized White | 8 participants |
| Region of Enrollment Bulgaria | 4 participants |
| Region of Enrollment Netherlands | 3 participants |
| Region of Enrollment Spain | 1 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Participants in Each Cluster
Clusters are described by an ellipse whose major and minor axes are the standard deviations in the x and y directions of the component points, which are rotated so that their covariance is equal to zero. The clusters were based upon the algorithms in which each data-point is assigned to one of four clusters: 1, 2, 3, or 4, representing no-target (negative controls \[NTCs\]), homozygotes one (XX), homozygotes two (YY), and heterozygotes (XY), respectively. Based on the calculated genetic composite scores from 8-single-nucleotide polymorphism (SNP)-based algorithm, participants were segregated into clusters.
Time frame: Baseline
Population: The analysis set included all participants who were enrolled and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Number of Participants in Each Cluster | Cluster 1 | 0 participants |
| All Participants | Number of Participants in Each Cluster | Cluster 2 | 4 participants |
| All Participants | Number of Participants in Each Cluster | Cluster 3 | 4 participants |
| All Participants | Number of Participants in Each Cluster | Cluster 4 | 0 participants |